Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

Condition(s) targeted: Alcohol Dependence

Intervention: Disulfiram (Drug); Acamprosate (Drug); Naltexone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Public Health Institute KTL

Official(s) and/or principal investigator(s):
Hannu Alho, MD, PhD, Study Director, Affiliation: National Public Health Institute, Department of Mental health and Alcohol Research

The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Official title: Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: Time(days) to first heavy drinking (HDD)day after medication started

Secondary outcome:

Time (days) to first drinking after medication started

Abstinence days (0 drinks/ day) by group

Average alcohol intake (weekly by group)

ALAT

GGT

SADD

AUDIT

EQ-5

Detailed description: Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy’s, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.

Objectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.

Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1: 1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months.

Minimum age: 25 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Alcohol dependence (ICD-10)

Exclusion Criteria:

- Clinically significant symptoms of alcohol withdrawal

- Significant recently diagnosed psychiatric disease (psychosis, personality disorder

or suicidal tendency that appeared during the initial interview)

- Current psychiatric disease demanding special treatment or medication including DSM-IV

determined drug dependence other than alcohol or nicotine dependence

- Current use of any opioids within four weeks before screening

- Significant brain, thyroid, kidney, uncompensated heart disease, or clinically

significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT > 200)

- Pregnancy, nursing, or women refused to use a reliable method for birth control

National Public Health Institute, Department of Mental Health and Alcohol Research, Helsinki 00251, Finland

Related publications:

Morley KC, Teesson M, Reid SC, Sannibale C, Thomson C, Phung N, Weltman M, Bell JR, Richardson K, Haber PS. Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial. Addiction. 2006 Oct;101(10):1451-62.

Starting date: September 2000
Ending date: April 2005
Last updated: February 15, 2007